Knee Replacement Implant Recalled Due to Potential Material Degradation
Knee replacement components recalled due to potential oxidation in UHMWPE material that could affect durability. Approximately 76 units distributed in the US with additional international distribution.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for potential material degradation in an orthopedic implant. While the hazard is theoretical with no reported injuries or failures, risk-of-harm products where injury has not yet been reported meet the High severity criterion.
Plain-English summary
The FDA is recalling the SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 (part number 73-0510), a component used in knee replacement surgery manufactured by Howmedica Osteonics Corp.
The recall is due to UHMWPE (ultra-high molecular weight polyethylene) raw material that is over 5 years old. Material of this age has the potential for elevated oxidation levels, which can negatively affect material properties and potentially compromise implant durability.
Approximately 76 units were distributed in the United States, with additional distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. Affected lot numbers include 57A2, 3WP6, E10K, X49N, WJ3L, and 38TY.
Patients and healthcare providers who have received this implant should contact Howmedica Osteonics Corp. for guidance on potential risks and recommended actions.
The recalled product
- Product
- SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- GTIN: 07613327050301 Lot Numbers: 57A2
- 3WP6
- E10K
- X49N
- WJ3L
- 38TY
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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